How Decision Making Drives Viral Testing
Before and After
[Devices Come to the Market and the Laboratory]
D. Kathleen Wright, Reviewer
Microbiology Division
Office of Diagnostic Device Evaluation and Safety
Center for Devices and Radiological Health
Food and Drug Administration
2098 Gaither Road, HFZ-440
Rockville, MD 20850
[Powerpoint Presentation]
Mission of OIVD
The mission of the Office of in Vitro Diagnostic Device Evaluation and Safety
(OIVD) is to provide comprehensive and integrated regulatory oversight for in
vitro diagnostic devices (IVDs) throughout their total product life cycle (TPLC).
Rationale for OIVD
The new office will apply IVD expertise across all premarket and postmarket
activities. It will shift the current focus on premarket review to a new emphasis
on cradle-to-grave oversight.
Combines the premarket IVD evaluation component of the Office of Device Evaluation
with the compliance/enforcement component of the Office of Compliance
Premarket Information
When a manufacturer wants to begin selling an IVD product, it must first submit
a premarket notification or premarket approval application to FDA. Premarket
notification is generally reserved for lower risk products, and premarket approval
is usually reserved for new technology and higher risk products.
Premarket Notification [510(k)]
In the premarket notification process, new products are compared to ones that
are already on the market. If FDA finds the new products to be substantially
equivalent to predicate devices on the market, it clears the product.
All products cleared through the premarket notification program [510(k)] are
listed in the 510(k) database. This database includes the name of the product,
the 510(k) number, and a copy of the clearance letter indicating the sponsor
of the submission. It also often includes the intended use of the device and
the manufacturer's summary.
The manufacturer's summary gives information on the studies done to demonstrate
that the new device is as safe and effective as its predicate. FDA does not
review it in depth. Instead of a summary, manufacturers may substitute a statement
saying that the summary will be available upon request. In this case, you will
not find the summary in the 510(k) database, but you can receive copies of it
directly from the sponsor. While the detail and format of the summary vary,
these documents can provide considerable information about the quality and nature
of a particular product.
De novo applications are 510(k)s that have no predicates, but because they
are considered to be low risk, they are reviewed under the 510(k) program. Their
510(k) summaries contain information on the studies that showed they were safe
and effective. De novo 510(k)s, and 510(k)s that subsequently cite them as predicate
devices, usually have special control guidance documents that give information
about how to obtain clearance.
Premarket Approval Application (PMA)
In the premarket approval application process, the sponsor presents data to
demonstrate that a new product is safe and effective for its intended use. If
FDA finds the new product to be safe and effective, it approves the product.
All products approved through the premarket approval application program (PMA)
are listed in the PMA database. Each entry includes a summary of safety and
effectiveness (SS&E) outlining in detail the scientific information used
to obtain premarket approval. The sponsor submitting the PMA drafts the SS&E,
but the final version is written and edited by FDA review staff.
Clinical Laboratory Improvement Amendments (CLIA)
FDA assigns a regulatory category to all commercially marketed in vitro diagnostic
tests, based on their potential risk to public health.
The CLIA '88 database lists all commercially marketed in vitro
test systems that FDA has categorized under the Clinical Laboratory
Improvement Amendments (CLIA '88) since January 31, 2000. It also
contains all tests categorized by the Centers for Disease Control
and Prevention (CDC) prior to that date. You can search the CLIA
'88 database by test system name, analyte name, complexity, specialty,
or date of categorization. Many of the records also contain links
to the 510(k) summary or the PMA summary of safety and effectiveness.
Postmarket Product Problems
FDA's databases of device problems are available to the public. The Medical
and User Facility Device Experience (MAUDE) give information on medical devices
that may have malfunctioned contributed to a death or serious injury. You can
also get information about recalls from FDA's list of medical device recalls.
Finding Information about IVD Products
FDA maintains a number of databases containing information about in vitro diagnostic
devices (IVDs) use for laboratory testing. You can use these databases to find
what products FDA has cleared or approved, review the studies FDA used to evaluate
the products, or research problems that occurred with different products.
http://www.fda.gov/cdrh/oivd/index.html
http://www.fda.gov/cdrh/
Other Sources of Information
Performance of tests may vary after enters the marketplace. Information on
the expected performance of an IVD is presented in its labeling or package insert.
You can obtain details about performance in actual clinical laboratories by
asking the manufacturer for a list of users to contact. For best results, you
should contact laboratories with operational environment similar to your own.
You can also find information on real world testing by analyzing the scientific
literature, by monitoring information on test performance through proficiency
testing programs, or by contacting any beta testing sites the sponsor used in
product development.
Goals of OIVD
- To make Total Product Life Cycle (TPLC) a functional reality
by allowing technical and administrative expertise to be applied
seamlessly to a continuum of regulatory processes.
- To provide a system for encouraging information flow and feedback
between the CDRH offices and divisions involved in the regulation
of IVDs, and to use this feedback to improve premarket and postmarket
oversight.
- To shift resources from premarket to postmarket assessment by
exploiting the current methods of defining IVD performance and
actualizing the spirit of the least burdensome provisions of FDAMA.
- To improve the timeliness of decision-making and staff interaction
while maintaining or improving current output.
- To overcome inherent limitations in the current approach to
premarket review that provides information at idealized laboratory
sites and without full information on the impact of manufacturing
(scale-up) in vitro diagnostic device performance.
- To develop new methods of postmarket monitoring of IVDs that
produce more complete pictures of real-world IVD device behavior.
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